Augmentin 250 mg/125 mg Film-Coated Tablets

Summary of Product characteristics

                                Health Products Regulatory Authority
03 July 2019
CRN0095H4
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin 250 mg/125 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amoxicillin trihydrate equivalent to 250 mg
Amoxicillin with potassium clavulanate equivalent to 125 mg
of clavulanic acid.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablets
_Product imported from the UK_
White to off-white, oval shaped, film-coated tablets engraved
Augmentin on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Augmentin is indicated for the treatment of the following infections
in adults and children (see sections 4.2, 4.4 and 5.1).
• Acute bacterial sinusitis (adequately diagnosed)
• Cystitis
• Pyelonephritis
• Cellulitis
• Animal bites
• Severe dental abscess with spreading cellulitis
Consideration should be given to official guidance on the appropriate
use of antibacterial agents
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except where doses are stated in terms of an
individual component.
The dose of Augmentin that is selected to treat an individual
infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
• The severity and the site of infection
• The age, weight and renal function of the patient as shown below.
The use of alternative presentations of Augmentin (e.g. those that
provide higher doses of amoxicillin and/or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary (see
sections 4.4. and 5.1).
For adults and children ≥ 40 kg, this formulation of Augmentin
provides a total daily dose of 750 mg amoxicillin/375mg
clavulanic acid, when administered as recommended below. If it is
considered that a higher daily dose of amoxicillin is required,
it is recommended that anot
                                
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